Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy
Ospedale Generale Di Zona Silandro
Information provided by (Responsible Party):
Dr. Gutwenger Ivana, Pure Mountain Solda
ClinicalTrials.gov Identifier:
NCT02013947
First received: November 6, 2013
Last updated: April 26, 2014
Last verified: April 2014
  Purpose

The metabolic syndrome is a cluster of metabolic disorders (obesity, hyperglycemia, dyslipidemia and hypertension) and it is a risk factor for the development of type 2 diabetes and atherosclerotic cardiovascular disease. There are several definitions for the metabolic syndrome. The AHA/NHLBI (American Heart association/National Heart Lung Blood Institution)and IDF (International Diabetes Federation)2009 criteria are frequently used to comparing data from studies. Prevention or reduction of obesity and lifestyle modification with physical activity is the main therapeutic goal in patients with metabolic syndrome. Recent studies have shown that exercise in moderate altitude or in moderate hypoxia improved glycemic parameters. The influence of training in moderate altitude on circulating metabolites and hormones in terms of substrate utilization is unclear. The adiponectin seems to play an important role in the homeostasis of adipose tissue and in the pathogenesis of the metabolic syndrome and physical activity seems to have a positive effect on adiponectin concentrations. In this study with randomized controlled pretest-posttest-design we want to investigate the effects of physical activity in moderate hypoxia on biomarkers of metabolic syndrome.


Condition Intervention
Metabolic Syndrome
Other: 2 weeks of exercise in low and moderate altitude

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial to Analyze the Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome.

Resource links provided by NLM:


Further study details as provided by Pure Mountain Solda:

Primary Outcome Measures:
  • exercise test [ Time Frame: examination after 2 weeks of exercise ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • BMI, BIA, metabolic and cardiorespiratory parameters [ Time Frame: examination on baseline and after the 2 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • blood pressure, heart rate [ Time Frame: at baseline and after 2 weeks of exercise ] [ Designated as safety issue: Yes ]
  • blood pressure, heart rate [ Time Frame: at baseline and after 2 weeks of exercise ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Moderate altitude group
2 weeks of exercise at 1900 meters sea level
Other: 2 weeks of exercise in low and moderate altitude

Group A will spend 2 weeks at an altitude of 1900m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).

Group B will spend spend 2 weeks at an altitude of 400m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).

low altitude group
2 weeks of exercise at 400 meters sea level
Other: 2 weeks of exercise in low and moderate altitude

Group A will spend 2 weeks at an altitude of 1900m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).

Group B will spend spend 2 weeks at an altitude of 400m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).


Detailed Description:

Participate can subjects aged 40-70 years with metabolic syndrome according to the definition of AHA/NHLBI and IDF 2009 after declaring orally and written consent and if they authorize to process personal and sanitary data. The study involve 80 subjects with metabolic syndrome. They will be recruited by general practitioner, elect from the principal investigator and invited to participate in the trial. The 80 participants will be randomized in two groups.

Group A, moderate altitude group, 1900 m, 40 participants Group B, low altitude group, 400m, 40 participants Group A will spend 2 weeks at an altitude of 1900m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).

Group B will spend spend 2 weeks at an altitude of 400m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).

Nutrition does not follow any specific diet plan, both groups receive an equivalent balanced feeding.

Clinical examinations at the beginning and at the end of the study laboratory tests well be documented and compared(fasting plasma glucose, triglycerides, HDL-C, LDL-C, insulin, C-peptid, free fatty acids, adiponectin, leptin, HbA1c, Metabolon cluster, c reactive protein, vit D3). Also BMI, BIA bioimpedance analysis, blood pressure, heart rate, egg, Physical status, exercise test.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

waist circumference in men >102 cm, in women >88cm serum triglycerides >150 mg/dl or drug treatment serum HDL cholesterol < 40 mg/dl in men or <50 mg/dl in women or drug treatment blood pressure >130/95 or drug treatment fasting plasma glucose >100 mg/dl or drug treatment 3 from this 5 criteria -

Exclusion Criteria:

positive anamnesis for myocardial infarction,chronic heart disease, cerebral ischemic occurrences , mental and psychic disorders, not controlled hypertension or hyperglycemia, tumor desease, lung disorders,pregnancy

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013947

Locations
Italy
Gutwenger Ivana
Bressanone, Bolzano, Italy, 39042
Sponsors and Collaborators
Pure Mountain Solda
Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy
Ospedale Generale Di Zona Silandro
Investigators
Principal Investigator: Ivana Gutwenger Pure Mountain Solda
  More Information

No publications provided

Responsible Party: Dr. Gutwenger Ivana, Dr. med. Gutwenger Ivana, Pure Mountain Solda
ClinicalTrials.gov Identifier: NCT02013947     History of Changes
Other Study ID Numbers: ESF 2/308/2010
Study First Received: November 6, 2013
Last Updated: April 26, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Pure Mountain Solda:
Exercise, moderate altitude, hypoxia, metabolic syndrome

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014